Director, Clinical Scientist
About The Position
About Summit Ivonescimab known as SMT112 is a novel potential first in class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD 1 with the anti angiogenesis effects associated with blocking VEGF into a single molecule Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD 1 and VEGF Summit has begun its clinical development of ivonescimab in non small cell lung cancer NSCLC with three active Phase III trials HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR mutated locally advanced or metastatic non squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI eg osimertinibHARMONi 3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first line metastatic NSCLCHARMONi 7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first line metastatic NSCLC whose tumors have high PD L1 expressionIvonescimab is an investigational therapy that is not approved by any regulatory authority in Summits license territories including the United States and Europe Ivonescimab was approved for marketing authorization in China in May 2024 Ivonescimab was granted Fast Track designation by the US Food & Drug Administration FDA for the HARMONi clinical trial setting Overview of Role The Director Clinical Scientist is responsible for leadingcontributing to study design and execution of clinical studies in hematologyoncology As a leader within the clinical organization this individual will be partnering with clinical operations translational and other matrix team members to design and refine clinical plans authoring key clinicalregulatory documents and ensuring exceptional delivery and interpretation of clinical data The Director Clinical Scientist will strive to drive study enrollment and build and maintain collaborative relationships with investigators and clinical site staff CROs and Summit colleagues The Director Clinical Scientist will foster a proactive and thoughtful approach to clinical study execution where obstacles are anticipated and effectively mitigatedresolved
Requirements
- MS or equivalent required; PhD PharmD or MD preferred
- Minimum of 5 years overall related experience with PhD or like degree; Minimum of 2 years experience in conducting supporting oncologyhematology clinical studies
- Excellent written and verbal communication skills
- Expertise in interpreting immunologyimmuno oncology translational data in addition to clinical data
Responsibilities
- LeadsContributes to study design and amendments in collaboration with internal and external scientific stakeholders
- Collaborates with MD regulatory and other internal partnersstakeholders with authoring and submission of protocols protocol amendments regulatory filings and other regulatory documentation
- Collaborates with clinical operations data management and CRO to develop and implement the overall data quality plan and leads internal medical data review and safety trend analysis on one or more studiesprograms
- Point of contact for clinical inquiries from CRO medical monitor and other stakeholders
- Develops and provides input for clinical presentation slides and other materials for internalexternal meetings andor ongoing communications eg investigator meetings pre study site selection visits study coordinator or clinical research administrator training study newsletters communications to study sites etc
- Partners with clinical operations and CRO in developing and maintaining study start up documentsresources eg ICF Lab Manual EDC Safety monitoring Plan etc
- Participates in safety meetings and tracks analyzes and reviews documentation for any potential safety events
- LeadsContributes to the development and implementation of communications strategies to support existing and concluded studies
- Includes KOL interactions advisory boards major medical meetings congresses and other events publications and other materials
- Writes andor reviews abstracts posters content for scientific meetings conferences other events and presentations and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders
- Coordinates submissions to scientific meetings andor other appropriate venues or groups
- Writes clinical science sections of meeting packages and assists in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes
- All other duties as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Director
Industry
Chemical Manufacturing
Education Level
Ph.D. or professional degree
